Regulators in Europe have approved Sanofi’s multiple sclerosis pill Aubagio.
The European Commission has granted marketing authorisation for Aubagio (teriflunomide) as a once-daily, oral therapy for the treatment of adults with relapsing remitting MS. The approval comes after the European Medicines Agency’s Committee for Human Medicinal Products issued a positive opinion on the drug in March.
The European thumbs-up is based on two Phase III trials which showed that Aubagio significantly reduced the annualised relapse rate and the time to disability progression at two years versus placebo. David Meeker, head of Sanofi’s Genzyme unit, said that “Aubagio’s efficacy, safety and convenient dosing may provide an attractive treatment option”.
The drug was approved in the USA in September and is also available in Australia, Argentina, Chile and South Korea. Second-quarter sales of Aubagio, which is competing in the USA with Biogen Idec’s MS pill Tecfidera (dimethyl fumarate) and Novartis’ Gilenya (fingolimod), reached 33 million euros.
